Tag: regulatory

The 10th annual ePharma Summit was held over the last few days in NY. I was interested due to some of the scheduled speakers but could not make it, so I dipped in and out of the virtual conference stream as possible and found some pretty worthwhile content in there. The most convenient way to follow was via #ePharma on Twitter, but the conference site also did a pretty good job of posting videos (although the audio was almost inaudible at times) and other information.

What ultimately prompted me to blog about it was a tweet (via @WendyBlackburn & @pjmachado) about a parody video produced by Kevin Nalty (@nalts) [see below]. It just struck me as creative, funny, and very strong work…and it made me think how great it would be if that kind of creativity could be unleashed to design social media/mobile/any type of health-related content aimed at informing, educating, and empowering patients. Yes, the creativity behind this video is being used for ‘good’, but minus the shackles it could be used for a much greater ‘good’. I think that social media, in particular, has a lot to offer on this front and it is unfortunate that the regulatory environment is such that this is largely not possible right now. There have been some efforts along these lines and there was even a preliminary paper just published on the use of Facebook to deliver HIV education. However, there remains a long way to go – and I’m not just talking about ‘official guidance’ in a single arena.

More anon, for now…I hope you enjoy the video.

@kevinclauson

Note: If you click on the video it may say it is restricted on certain sites as it contains content from Universal Music Group and must be played on You Tube…so you can click ‘Watch on YouTube’ to play or go to the epharmify Channel to view it.

Recently I had the pleasure of attending and presenting at the 3rd Annual Anti-Infectives Summit in Philadelphia. It was a good opportunity to interact and see presentations by people from medicinal chemistry, biochemistry, regulatory, and other backgrounds involved in drug discovery and research. I don’t deal much these days with the preclinical perspective, so it was a refreshing change of pace. I always appreciate the chance for cross-pollination of ideas with people from different areas.

There were a number of particularly good presentations, and one common theme that I saw was the borderline-inspiring enthusiasm by the researchers. You can always tell when someone truly loves what they do and is genuinely excited by their work – and I definitely saw that. Notables included Ying Zhang, MD, PhD, from Johns Hopkins, who opened my eyes in his presentation on issues with persister bacteria and Jennifer Schranz, MD from Cempra, who gave a great overview on the FDA’s expectations for clinical trials. She took what could have been a dry topic and infused it with energy and pace – I wish I could poach her to guest lecture in one of our drug information courses on this topic.

Something else that came out of the presentations was the increased emphasis on PROs (patient reported outcomes) in clinical trials. Considering that the immediate past-director of the NIH (Elias Zerhouni) made a statement about the increasing importance of the participatory medicine model…I think it was just a question of “when”, not “if”. That point spurred several interesting chats about PROs, ePatients, Phase IV, and the development of Pharmacovigilance 2.0.

Overall it was a very positive experience. I enjoyed some science refereshers, regulatory navigation tips, and insight into the future of anti-infective drug development.

@kevinclauson

Edit: I used an audience response system (aka clickers) in my presentation and included those slides here. However, I did not use the actual attendees’ responses in the slide deck I uploaded.